Solta Medical Receives FDA 510(k) Clearance for Thermage FLX™ System, Newest Generation Skin Smoothing Technology

BOTHELL, Wash., Oct. 4, 2017 /PRNewswire/ -- Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLX™ System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the face, eyes, and body.

Thermage FLX is the newest generation of Thermage^® technologies known for non-invasively reducing the appearance of fine lines and wrinkles.  The system uses patented radiofrequency technology to create a uniform heating effect in the deep collagen-rich layers of the skin. This gentle heating tightens existing collagen and stimulates the production of new collagen, all with little-to-no downtime for the patient. The Thermage FLX features a new optimized energy delivery algorithm, known as AccuREP™ technology, which automatically measures and precisely tunes the amount of energy delivered to the patient and treatment area. The system also features a new vibrating hand-piece to help enhance patient comfort, and a new, larger treatment tip that reduces treatment time by 25 percent. 

"As pioneers in the aesthetic market, Solta Medical has continued to evolve the Thermage technology to improve upon the efficacy, comfort, and results physicians and their patients have come to expect from the brand," said James Hartman, vice president and general manager, Solta Medical. "The FDA 510(k) clearance of Thermage FLX marks a momentous occasion during the brand's 15 year anniversary and demonstrates our commitment to our customers as we continue to develop innovative ways to improve on our existing technologies." 

According to the American Society for Aesthetic Plastic Surgery (ASAPS), the number of skin tightening procedures increased over 77% between 2014 and 2016. With the launch of the Thermage FLX system, Solta Medical is well positioned to help practices take advantage of this continuously growing trend. And while busy consumers continue to look for ways to maximize the use of their time, Thermage FLX treatments are now faster than ever, allowing patients to quickly return to their daily routine.

"Being among the first adopters of the technology, I have confidently used the system for over a decade, as it is the center-piece of a successful skin tightening program," said Michael S. Kaminer, M.D., founding partner of SkinCare Physicians. "The Thermage system, backed by more than 50 clinical studies, is the gold standard in our practice and our most popular skin smoothing treatment. I'm excited to see what the new Thermage FLX system has to offer as each subsequent version has proven to exceed my expectations."

The new Thermage FLX system is expected to be commercially available during the last quarter of 2017.

About Solta Medical 
Solta Medical, a division of Valeant Pharmaceuticals North America LLC, is a global leader in the medical aesthetics market that helps drive revenue growth to aesthetic practices by providing innovative and effective skin rejuvenation and body contouring solutions. Solta offers seven aesthetic energy devices to address a range of skin-related concerns, including skin resurfacing and rejuvenation, body contouring, fat reduction, skin smoothing, hair removal, and acne reduction. More than five million procedures have been performed with Solta Medical's portfolio of products around the world. More information can be found at www.solta.com.

About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com. 

Forward-looking Statements
This press release may contain forward-looking statements which may generally be identified by the use of the words "anticipates, "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.

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SOURCE Solta Medical

Related Links

http://www.solta.com